Standard Operating Procedure for Storage Conditions of Lotions
1) Purpose
The purpose of this SOP is to define the appropriate storage conditions for lotions to maintain their stability, integrity, and efficacy throughout their shelf life.
2) Scope
This SOP applies to all personnel involved in the handling, storage, and distribution of lotions within the pharmaceutical manufacturing facility.
3) Responsibilities
The responsibilities for executing this SOP are as follows:
Warehouse Personnel:
- Ensure lotions are stored according to the specifications outlined in this SOP.
- Monitor storage conditions regularly to maintain compliance.
Quality Control Personnel:
- Verify that storage conditions comply with regulatory requirements and product specifications.
- Monitor environmental conditions in storage areas.
Quality Assurance Personnel:
- Ensure that the storage conditions are documented and reviewed regularly.
- Investigate and address any deviations from specified storage conditions.
4) Procedure
4.1 General Storage Conditions:
- Store lotions in a dedicated area that meets the specified environmental conditions (temperature, humidity, light exposure).
- Ensure storage areas are clean, dry, and free from contaminants.
4.2 Specific Storage Conditions:
- Temperature: Store lotions at the specified temperature range, typically between 15°C to 25°C, unless otherwise specified by product stability data.
- Humidity: Maintain humidity levels within acceptable limits to prevent moisture absorption or loss.
- Light Exposure: Protect lotions from direct sunlight or artificial light sources that could degrade sensitive ingredients.
- Container Integrity: Ensure
lotions are stored in tightly sealed containers to prevent contamination and maintain product integrity.
4.3 Monitoring and Documentation:
- Regularly monitor and record storage conditions, including temperature and humidity levels.
- Document storage conditions in the designated logbook or electronic system.
4.4 Handling Procedures:
- Follow proper handling procedures when retrieving lotions from storage to prevent damage or contamination.
- Use FIFO (First In, First Out) method to ensure older stock is used first.
5) Abbreviations, if any
FIFO: First In, First Out
6) Documents, if any
- Storage Condition Logbook
- Product Stability Data
7) Reference, if any
- ICH Q1A(R2): Stability Testing of New Drug Substances and Products
- USP General Chapter <1079>: Good Storage and Distribution Practices
8) SOP Version
Version 1.0
